Compression and tension instruments and methods of use to reinforce ligaments

ABSTRACT

The disclosure provides apparatus and methods of use pertaining to syndesmosis reinforcement. Embodiments include a clamp having two jaws that extend toward each other to clamp two bone portions therebetween. The clamp may include an angle gauge and an adjustment mechanism having a force gauge that combine to enable the compression of the two bone portions in an optimal direction or angle and at an optimal, measurable compression force. Embodiments also include a tension instrument configured to knotlessly lock a flexible strand construct between two anchors at the same optimal direction and tension applied by the clamp. Further embodiments include an exemplary syndesmosis reinforcement procedure that employs the clamp and the tension instrument to construct a ligament reinforcement construct that achieves optimal anatomic positioning in both directional alignment and the reduction force applied by the construct. Other embodiments are disclosed.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This application claims the benefit under 35 U.S.C. 119(e) of U.S.Provisional Patent Application Nos. 62/358,231, filed Jul. 5, 2016 byJustin Taber and T. Wade Fallin for “LIGAMENT REINFORCEMENT DEVICES ANDMETHODS,” 62/425,560 filed Nov. 22, 2016 by Justin Tabor, PhinitPhisitkul, and T. Wade Fallin for “LIGAMENT REINFORCEMENT DEVICES ANDMETHODS,” 62/456,217, filed Feb. 8, 2017 by Justin Taber and T. WadeFallin for “PLATE AND LOOP CONSTRUCT,” and 62/458,975, filed Feb. 14,2017 by Matthew Karam, Phinit Phisitkul, Justin Taber, and T. WadeFallin for “PELVIC FRACTURE REPAIR,” all of which patent applicationsare hereby incorporated herein by reference.

REFERENCE TO CO-FILED APPLICATIONS

This application was co-filed with the following U.S. patent applicationSer. No. 15/641,573, on Jul. 5, 2017: by T. Wade Fallin, Justin Taber,Matthew Karam, and Phinit Phisitkul for “INTRA JOINT STABILIZATIONCONSTRUCT,” (Attorney Docket No. 81243.0001); Ser. No. 15/641,592 by T.Wade Fallin, Justin Taber, Matthew Karam, and Phinit Phisitkul for“EXTRA JOINT STABILIZATION CONSTRUCT,” (Attorney Docket No. 81243.0002);Ser. No. 15/641,600 by Justin Taber and T. Wade Fallin for “NONCIRCULARBROACH AND METHODS OF USE,” (Attorney Docket No. 81243.0003); and Ser.No. 15/641,618 by Phinit Phisitkul, Justin Taber, and T. Wade Fallin for“MULTIPLE SUTURE THREADER AND METHODS OF USE,” (Attorney Docket No.81243.0004); all of which patent applications are incorporated herein byreference.

BACKGROUND

Ligaments interconnect bones of the skeletal system and are involvedwith the stabilization and kinematics of skeletal joints. Variousinjuries may occur that result in compromised ligament function. Suchinjuries include, for example, partial and complete tears and avulsionof the bone where a ligament attaches to a bone. Ligament injuries occurthroughout the skeletal system.

By way of example, the human ankle 100 is a complex junction of multiplebones and soft tissues, as shown in FIGS. 1-3. The ankle 100 includesjoints between the tibia 102, fibula 104, and talus 106. The jointbetween the tibia 102 and fibula 104 is a syndesmosis or slightlymovable joint in which the bones are joined together by connectivetissue. The syndesmosis between the tibia 102 and fibula 104 includesthe anterior inferior tibiofibular ligament (AITFL) 110, the posteriorinferior tibiofibular ligament (PITFL) 112, and the interosseousligament (IOL) 114. The syndesmosis ligaments are often injured in highankle sprains. Other injury prone ligaments of the ankle joint include,among others, the anterior talofibular ligament (ATFL) 120, theposterior talofibular ligament (PTFL) 122 and the deltoid ligamentcomplex 124 including superficial and deep deltoid ligaments. Currentimplants, instruments, and methods used to reinforce ligaments topromote healing and normal joint function present a number ofchallenges, and improvements are needed.

SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key aspects oressential aspects of the claimed subject matter. Moreover, this Summaryis not intended for use as an aid in determining the scope of theclaimed subject matter.

One embodiment provides a clamp for compressing first and second boneportions together to reduce a space therebetween. The clamp includes abody comprising opposing first and second ends, the first and secondends comprising respective first and second jaws that define alongitudinal clamp axis, the first jaw engageable with the first boneportion and the second jaw engageable with the second bone portion todefine a directional force vector between the first and the second boneportions that is coaxial with the longitudinal clamp axis. The clampalso includes an adjustment mechanism coupled with the second jaw andconfigured to translate the second jaw distally toward the first jawalong the longitudinal axis to compress the first and the second boneportions between the first and the second jaws. The adjustment mechanismincludes a force gauge configured to indicate a compression force placedupon the first and the second bone portions by the first and the secondjaws along the directional force vector.

Another embodiment provides a tension instrument for tensioning andknotlessly locking a flexible strand having first and second opposingflexible strand ends, where the first flexible strand end is fixedadjacent to a first member, and the second flexible strand end is freeproximal to the first member and adjacent to a second member. Thetension instrument comprises a member engagement feature configured toengage with the second member through which the second flexible strandend passes and an adjustment mechanism operably coupled to a proximalend of the member engagement feature. The adjustment mechanism includes(a) a selectively adjustable flexible strand clamp configured to capturethe second flexible strand end and translate the second flexible strandend proximally relative to the member engagement feature to place atensile force on the flexible strand between the first and the secondmembers; (b) a force gauge operably coupled with the selectivelyadjustable flexible strand clamp, the force gauge including forceindicia to provide an indication of the tensile force placed on theflexible strand; and (c) a pathway extending through the adjustmentmechanism from a proximal end to a distal end adjacent the memberengagement feature to provide clearance for fixation hardware thatknotlessly locks the second flexible strand end relative to the secondmember to maintain the tensile force between the first and the secondflexible strand ends.

Yet another embodiment provides a method of reinforcing a syndesmosisjoint of a patient using: (a) a clamp having first and second opposingjaws that define a longitudinal clamp axis, an angle gauge configured toset an angle of the longitudinal clamp axis relative to a reference lineof a patient's anatomy, and an adjustment mechanism configured to applya measurable compression force along a directional force vector betweenthe first and the second clamp jaws that is coaxial with thelongitudinal clamp axis; and (b) a tension instrument having an anchorengagement feature coupled with an adjustment mechanism configured placea measurable tensile force on a flexible strand extending between afirst anchor in a first bone portion and a second anchor in a secondbone portion. The method includes the steps of (i) using the anglegauge, positioning the clamp such that the first jaw is engaged with thefirst bone portion and the second jaw is engaged with the second boneportion at a desired angle of the directional force vector relative tothe reference line of the patient's anatomy; (ii) actuating theadjustment mechanism of the clamp to translate the second jaw of theclamp distally to achieve a desired compression force between the firstand the second bone portions along the directional force vector; (iii)noting the desired compression force reflected upon a force gauge of theadjustment mechanism of the clamp; (iv) inserting a guide along thelongitudinal clamp axis through the first jaw and into the first and thesecond bone portions to form a bone tunnel extending between the firstand the second bone portions; (v) removing the clamp, leaving the guidein position; (vi) affixing a first end of a flexible strand to a firstfixation anchor; (vii) using the guide, pulling a second end of theflexible strand through the bone tunnel to insert the first fixationanchor into the bone tunnel at the second bone portion; (viii) threadingthe second end of the flexible strand flexible strand through a secondfixation anchor; (ix) inserting the second fixation anchor into the bonetunnel at the first bone portion; (x) engaging the anchor engagementfeature of the tension instrument with the second fixation anchor; (xi)using the adjustment mechanism of the tension instrument, pulling thesecond end of the flexible strand until a desired tensile force isplaced on the flexible strand between the first and the second boneportions, as reflected upon a force gauge of the adjustment mechanism ofthe tension instrument, wherein the desired tensile force equals thedesired compression force applied through the clamp; and (xii) accessingthe second fixation anchor through a pathway through the tensioninstrument, knotlessly locking the second end of the flexible strand inrelation to the second fixation anchor.

Additional objects, advantages and novel features of the technology willbe set forth in part in the description which follows, and in part willbecome more apparent to those skilled in the art upon examination of thefollowing, or may be learned from practice of the technology.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention,including the preferred embodiment, are described with reference to thefollowing figures, wherein like reference numerals refer to like partsthroughout the various views unless otherwise specified. Illustrativeembodiments of the invention are illustrated in the drawings, in which:

FIG. 1 illustrates a right view of a human ankle joint;

FIG. 2 illustrates a front view of a human ankle joint;

FIG. 3 illustrates a rear view of a human ankle joint;

FIG. 4 illustrates a front view of one embodiment of a clamp instrumentfor compressing two bone portions together;

FIG. 5 illustrates two alternative embodiments of a first jaw of theclamp instrument of FIG. 4;

FIG. 6 illustrates another front view of the clamp instrument of FIG. 4;

FIG. 7 illustrates a longitudinal cross-sectional view of an adjustmentmechanism of the clamp instrument of FIG. 4;

FIGS. 8-9 illustrate transverse cross-sectional views of a first end ofthe clamp instrument of FIG. 4 in respective closed and openconfigurations;

FIG. 10 illustrates the clamp instrument of FIG. 4 with a patient'stibia and fibula compressed therebetween;

FIG. 11 illustrates a perspective view of a force gauge of the clampinstrument of FIG. 4;

FIG. 12 illustrates a top view of a tension instrument for tensioning aflexible strand to a known amount of tension force;

FIG. 13 illustrates a side view of the tension instrument of FIG. 12;

FIG. 14 illustrates a bottom view of the tension instrument of FIG. 12;

FIG. 15 illustrates an exploded view of the tension instrument of FIG.12, as cannulated to permit a shaft of a set screw driver to passthrough the cannula to insert a set screw into a fixation anchor;

FIG. 16 provides a flowchart detailing an exemplary syndesmosisreinforcement procedure using the clamp instrument of FIG. 4 and thetension instrument of FIG. 12;

FIGS. 17-21 illustrate the operative steps described in the flowchart ofFIG. 16;

FIG. 22 illustrates a number of supplemental flexible strands attachedto a locking anchor used in the syndesmosis reinforcement proceduredescribed and illustrated in FIGS. 16-21; and

FIG. 23 illustrates a bone plate substituted for a first anchor used inthe syndesmosis reinforcement procedure described and illustrated inFIGS. 16-21.

DETAILED DESCRIPTION

Embodiments are described more fully below in sufficient detail toenable those skilled in the art to practice the system and method.However, embodiments may be implemented in many different forms andshould not be construed as being limited to the embodiments set forthherein. The following detailed description is, therefore, not to betaken in a limiting sense.

The technology discussed herein relates to apparatus and correspondingmethods of use for preparing ligament reinforcement constructs. In oneembodiment, a compression instrument, or clamp, provides a mechanism forclamping bone portions together to reduce the space therebetween with aforce vector having both a known direction and a known magnitude.Embodiments of the clamp may provide a pin guide for inserting a pincoaxial with the force vector and may include features to facilitaterapid application of clamping pressure as well as fine tuning of theclamping pressure. Embodiments of the clamp may provide multiple modesof operation, including one-way incremental clamping and dynamic,continuously adjustable clamping. In other embodiments, the clamp mayinclude a quick release mechanism to release clamping pressure. Theclamp may also include a depth gauge for indicating the length of a paththrough a bone coaxial with the force vector.

FIGS. 4-11 illustrate one exemplary embodiment of a compressioninstrument or clamp 600 having a bow-shaped body 602 defining alongitudinal clamp axis 604. A first end 606 of the body 602 includes afirst jaw 608 that extends proximally toward a second end 610 of thebody 602. As shown in FIG. 5, one embodiment of the first jaw 608located at the first end 606 may feature a v-notch 608 a that registerson and is engageable with a bone portion. In this embodiment, the firstjaw 608 may be rigidly attached to the first end 606 and include thev-notch 608 a formed by an angled opening directly engageable with acurved bone surface. The angled opening may be shaped to engage theshaft of a fibula, a malleolus, or any other desired bone location. Forexample, the first jaw 608 may be formed by making an angled cut througha tubular body to create the v-notched jaw 608 a having opposed anglededges diverging toward the second end 610 of the body 602, as shown. Inanother embodiment, the first jaw 608 may feature a spherical end 608 bconfigured to register on a bone plate. In both end embodiments 608 a-b,the first jaw 608 is intersected by the clamp axis 604.

The second end 610 of the body 602 defines a receiver 612 able to mounta second jaw 614 for movement relative to the first jaw 608 along theclamp axis 604. In the example of FIGS. 4-11, the second jaw 614includes a point contact element 615 engageable with a bone portion todefine a directional vector between the first and the second jaws 608,614, and thus the two bone portions, that is parallel or, as may be morespecifically, coaxial with the clamp axis 604. The orientation isreferred to hereinafter as “coaxial” but may be parallel as well. In theexample of FIGS. 4-11, the point contact element 615 may form asharpened spike able to engage with a bone surface.

In this embodiment, the second jaw 614 is mounted to an adjustmentmechanism 616, detailed in the cross-sectional view of FIG. 7. Theadjustment mechanism 616 includes an inner shaft 618, a hollow outershaft 620 (i.e., sleeve), a release trigger 622, a force gauge 624, anda handle 626. The release trigger 622 is mounted in a translatingrelationship transverse to the clamp axis 604 and includes a screwthread 627 along its lower edge. The outer shaft 620 extends through athrough hole 625 in the receiver 612 from a proximal end 628 to a distalend 630 coaxial with the clamp axis 604. The proximal end 628 of theouter shaft 620 is fixed to the force gauge 624. The inner shaft 618 iscoaxially received within the outer shaft 620 and the force gauge 624and is affixed to the handle 626 at its proximal end in an axial forceand torque transmitting relationship via a pin 631. The second jaw 614is mounted to the distal end 630 of the outer shaft 620. A first offset621 separates the proximal end of the force gauge 624 and the proximalend of the inner shaft 618, and a second offset 623 separates the secondjaw 614 from the distal end of the inner shaft 618.

The force gauge 624 is a hollow cylinder received within a gap 636between the handle 626 and the inner shaft 618. A force spring 640biases the force gauge 624 distally away from the handle 626; a returnspring 642 biases the distal end of the inner shaft 618 proximally awayfrom the receiver 612; and a trigger spring 644 biases the triggerpartial threads 627 into engagement with external threads 646 formed onthe inner shaft 618.

The receiver includes loops 650, 652 forming finger grips, and thehandle 626 includes a groove 654 forming a thumb grip. In use, a usermay place one or more fingers in the finger loops 650, 652 and applypressure to the handle 626 with a thumb engaged in the thumb groove 654.This provides a syringe-like grip such that the handle 626 may bepressed distally. The threads 646 on the inner shaft 618 and the threads627 on the lower portion of the trigger 622 are formed such that distalmotion of the inner shaft 618 wedges or arcs the upper portion of thetrigger 622 proximally, against the biasing of trigger spring 644, andallows the inner shaft 618 to ratchet forward (along with the outershaft 620) upon the advancement of the handle 626 for gross adjustmentcontrol of the clamp 600.

To provide fine adjustment control of the clamp 600, the handle 626 maybe rotated to minimally advance the inner and outer shafts 618, 620 byadvancing the inner shaft threads 646 relative to the trigger threads627. The threads 646 of the inner shaft 618 and the threads 627 of thelower portion of the trigger 622 engage to prevent proximal motion ofthe inner shaft 618 relative to the release trigger 622. A user may pullthe release trigger 622 proximally to move or arc the trigger threads627 upwardly and release the inner shaft 618 so that the inner shaft 618and the outer shaft 620 may automatically be biased proximally by thereturn spring 642.

When the second jaw 614 engages another object (e.g., bone) that resistsits distal motion relative to the first jaw 608, and the inner shaft 618is advanced further, the handle 626 will advance over the casing of theforce gauge 624 through the offset 621, thereby compressing the forcespring 640 as the handle 626 moves over the force gauge 624. The amountof force required to advance the inner shaft 618, and thus the handle626, distally is proportional to the distance the force spring iscompressed from its resting position. Thus, the compression or jointreduction force placed upon the bone portions positioned between thefirst jaw 608 and the second jaw 614 is indicated by reading the forceindicia 666 (e.g., 10 lbs., 20 lbs., 30 lbs.) on the force gauge 624relative to an edge 668 of the handle, as detailed in FIGS. 10-11.

In this embodiment, the body 602 of the clamp 600 includes an anglegauge 680 in the form of angle indicia 682 on a portion of the bowshaped body 602 between the first and second ends 606, 610. The indicia682 are graduated so that a reference feature such as, for example, areference line defined by portions of a patient's body, will align withthe zero-degree mark when the reference line is perpendicular to theclamp axis 604. Angular marks on either side of the zero-degree markindicate the amount of angular deviation of the reference line from theperpendicular, as shown in FIG. 17.

Using the angle gauge 680 in combination with the gauged clampingmechanism provided by the first and second jaws 608, 614, describedabove, the clamp 600 provides an optimal functional outcome thatcombines the compression or clamping of two bone portions together inthe correct direction along an axis of the native ligament with anintegrated force measurement that ensures the application of the correctclamping force needed to provide the requisite compression (e.g.,oftentimes approximately 25-30 lbs. or, as commonly known in theindustry, the approximate amount of force needed to crush an aluminumcan).

In the embodiment of FIGS. 4-11, the first end 606 of the body 602includes a C-shaped arm 684, as shown in the lateral cross-sectionalviews of the first end 606 of FIGS. 8-9. A sheath 686 forming a U-shapedgroove 688 is rotatively coupled about the C-shaped arm 684. When thesheath 686 is manually rotated into a closed configuration 690, shown inFIG. 8, the U-shaped groove 688 is blocked by the wall of the C-shapedarm 684, such that a user may use the blocked U-shaped groove 688 as aguide for the insertion of a drill, a length of k-wire, and/or a pin 804into the bone portions compressed between the first and second jaws 608,614 of the clamp 600, as shown in FIG. 10. Conversely, when the sheath686 is manually rotated into an open configuration 692, shown in FIG. 9,the first end 606 of the clamp 600 essentially contains an open slotthat allows the drill, length of k-wire, or pin 804 to pass unimpededfrom the open U-shaped groove 688 in a direction transverse to thelongitudinal clamp axis 604. As a result, the entire clamp 600 maydisengaged from the bone portions clamped therein and transverselylifted away from the clamping site, leaving only the drill, k-wire, orpin 804 in place. In further detail and as shown in FIG. 10, when thesheath 686 is rotated into the closed configuration 690, the user maydrill from a distal end of the first end 606 of the body 602 toward thebone portions clamped between the first and second jaws 608, 614. Whenthe sheath 686 is rotated into the open configuration 692, the user mayslip the drill or other hardware in a direction transverse to the axis604 from the first end 606 of the clamp 600 through the open U-shapedgroove 688 before disengaging the entire clamp 600 from the compressedbone portions and removing it from the clamp site. Using the closed andopen configurations 690, 692 of the U-shaped groove 688, the clamp 600may be employed in a variety of functional capacities, including theinitial drilling of a bone tunnel, fixation of hardware, or as astabilization device applied to realign bone tunnels after they havebeen drilled and have deviated from alignment.

FIGS. 12-14 illustrate front, side, and rear views of one embodiment ofa tension instrument 700 able to tension a suture or other flexiblestrand to a known amount of tension force. In this regard, the tensioninstrument 700 may be used to recreate the tension force applied via theclamp 600, discussed above, before enabling lockout of the suture at thecorrect tension using a variety of fixation hardware and/or fixationtechniques. The disclosed devices may be used in conjunction with aflexible synthetic strand such as, for example, a suture, a suture tape,a cable, or another suitable flexible synthetic strand (hereinafter a“flexible strand,” “flexible synthetic strand,” or “suture”).

In this embodiment, the tension instrument 700 is arranged proximallylike the clamp 600 of FIGS. 4-11 with an adjustment mechanism 716including an inner shaft 718, a hollow outer shaft 720, a trigger 722, aforce gauge 724, a handle 726, and a receiver 712, all configured as inthe clamp example discussed in relation to FIGS. 4-11 above. In theexample of FIGS. 12-14, the outer shaft 706 includes a distal end 711and a fastener engagement feature 713 at its distal end configured likethat of the distal end of the counter-torque anchor driver 570 disclosedin FIGS. 15-18 of U.S. patent application Ser. No. 15/641,592, entitled“EXTRA JOINT STABILIZATION CONSTRUCT” (Attorney Docket No. 81243.0002)and co-filed with this application on Jul. 5, 2017.

FIG. 15 illustrates that the tension instrument 700 includes a cannula719 and is cannulated proximally to distally to permit a shaft of a setscrew driver 717 and a set screw like, for example, that disclosed inFIGS. 5-7, 12, and/or 15-18 of U.S. patent application Ser. No.15/641,592, entitled “EXTRA JOINT STABILIZATION CONSTRUCT” (AttorneyDocket No. 81243.0002) and co-filed with this application on Jul. 5,2017 to pass through the cannula 719 in order to insert the set screwinto an anchor like that disclosed in, for example, FIG. 5-7 or 12-14 ofU.S. patent application Ser. No. 15/641,592, entitled “EXTRA JOINTSTABILIZATION CONSTRUCT” (Attorney Docket No. 81243.0002) and co-filedwith this application on Jul. 5, 2017 that is attached to the tensioninstrument 700.

In the example of FIGS. 12-14, the receiver 712 of the tensioninstrument 700 includes a flexible strand clamp 730 or suture clamp 730(referred hereinbelow as suture clamp 730) including a moveable jaw 732and a thumb screw 734. A suture may be placed between the receiver 712and the moveable jaw 732 and clamped in place by tightening the thumbscrew 734. With the distal end of the tension instrument engaging orleveraging off of adjacent member such as a bone, anchor, or anothermember through which a suture passes, and with the suture secured in thesuture clamp 730, the receiver 712 may be moved proximally relative tothe inner shaft 718. As tension increases in the suture, the outer shaft720 and the force gauge 724 are forced distally relative to the innershaft 718, causing the handle 726 to move over the force gauge 724against the force spring (not shown). The tension in the suture may beread on the force gauge relative to the edge 768 of the handle. Thetension instrument 700 may be used in conjunction with an interferencescrew, anchor, or any other appropriate fixation hardware to recreatethe correct tension force and lock the suture in place.

The exemplary instruments of FIGS. 4-15, as well as the exemplaryanchors disclosed in U.S. patent application Ser. No. 15/641,592,entitled “EXTRA JOINT STABILIZATION CONSTRUCT” (Attorney Docket No.81243.0002) and Ser. No. 15/641,573, entitled “INTRA JOINT STABILIZATIONCONSTRUCT” (Attorney Docket No. 81243.0001) both co-filed with thisapplication on Jul. 5, 2017, may be used to form ligament reinforcementconstructs. By way of general explanation, a first suture anchor may bepositioned at a first ligament attachment point on a bone. A suture maybe routed from the first suture anchor to a second, locking sutureanchor at a second ligament attachment point on a bone. The suture maybe tensioned to provide a desired level of reinforcement of the ligamentand then locked with the second suture anchor. Ligament reinforcingconstructs may be provided for any ligament of the skeletal system. Forexample, various ligament reinforcement constructs will be illustratedfor the human ankle. In one example, an anchor is placed in theproximity of the origin of a ligament and a second anchor is placed inthe proximity of the insertion of the ligament. One anchor may be anyordinary suture returning anchor, and the second anchor may be aknotless suture locking anchor. The ligament may also undergo a directrepair, e.g., mid substance suturing. In examples of the ankle, theligaments may include the AITFL, PITFL, ATFL, PTFL, the deep andsuperficial ligaments of the deltoid complex, and/or any other ligamentin need of reinforcement.

In one example, a reinforcement of the interosseous ligament (IOL) 114(FIG. 3) may be used to stabilize the ankle syndesmosis. FIG. 16provides a flowchart detailing the steps of an exemplary syndesmosisreinforcement procedure 1100, while FIGS. 17-21 illustrate thecorresponding steps of the exemplary syndesmosis reinforcementprocedure. To begin, as shown in FIG. 17, the clamp 600 is positionedsuch that the v-notch 608 a of the first jaw 608 is engaged with thefibula 104 on the lateral side of the ankle, and the point 615 of thesecond jaw 614 is positioned over the tibia 102 on the medial side ofthe ankle (FIG. 16, 1102). The angle gauge 680 may be used to set theangle of the clamp axis relative to reference line of the patient'sanatomy, e.g., a midline 802 of the foot. For example, it has been foundby the present inventors that a force vector of around 30 degrees fromperpendicular often provides the best reduction of the fibula relativeto the tibia. With the clamp 600 in this initial position, the jaws canbe closed to reduce the syndesmosis (FIG. 16, 1104). The ankle can bemoved through a range of motion and the reduction evaluated. Thereduction force may be increased or decreased by adjusting the clamppressure and the force direction may be varied by repositioning one orboth jaws 608, 614 of the clamp 600 on the bones. The amount of forceused to achieve the desired reduction can be read and noted from theforce gauge 624.

Once a desired reduction has been achieved, the pin 804 (or a k-wire,etc.) is inserted along the clamp axis 604 through the bones toestablish the reinforcement vector direction, as shown in FIG. 10 (FIG.16, 1106). The clamp may then be removed by rotating the sheath 686 suchthat the U-shaped groove 688 moves into the open configuration 692 andlifting the clamp from the compression site, as discussed above inrelation to FIGS. 8-10 (FIG. 16, 1108). Alternatively, the procedure maycontinue through the clamp 600.

In FIGS. 18-19, the clamp 600 has been removed, and a drill 806 isadvanced part-way over the pin 804 to provide clearance for the shaft ofa first anchor 808, e.g., anchor 920 disclosed in FIGS. 6-12 of U.S.patent application Ser. No. 15/641,573, entitled “INTRA JOINTSTABILIZATION CONSTRUCT,” (Attorney Docket No. 81243.0001) co-filed withthis application on Jul. 5, 2017, if necessary as shown in FIG. 18 (FIG.16, 1110). Alternatively, the pin 804 may be sized to provide the rightsize hole for the anchor shaft or an anchor without a shaft may be usedsuch as button 200 disclosed in FIG. 4 of U.S. patent application Ser.No. 15/641,573, entitled “INTRA JOINT STABILIZATION CONSTRUCT” (AttorneyDocket No. 81243.0001) co-filed with this application on Jul. 5, 2017. Asuture 810 is attached to the first anchor 808 and pulled through thebone tunnel, e.g., by threading the suture 810 through an eye in the pin804 and pulling the pin and the suture through the bones in thedirection of arrow 813, as shown in FIG. 19 (FIG. 16, 1112). The sutureis next threaded through a second anchor 812 such as, for example,anchor 300 disclosed in FIGS. 13-19 of U.S. patent application Ser. No.15/641,573, entitled “INTRA JOINT STABILIZATION CONSTRUCT” (AttorneyDocket No. 81243.0001) co-filed with this application on Jul. 5, 2017(FIG. 16, 1114). Then the second anchor 812 is engaged with the bone(FIG. 16, 1116), the tension instrument 700 is engaged with the secondanchor 812 (FIG. 16, 1118), and the suture is clamped within the sutureclamp 730 of the tension instrument 700, as shown in FIG. 20 (FIG. 16,1120). Tension is applied to the suture to match the force used to clampthe joint and obtain the desired reduction (FIG. 16, 1122) and thesuture is knotlessly locked (FIG. 16, 1124), as shown in FIGS. 20-21. Inthis manner, the directional force vector determined/set during thereduction with the clamp 600 is reproduced precisely, both in directionand force amplitude, by the suture construct.

If desired, the ends of the suture coming from the second locking anchor812 may be trimmed. Alternatively, they may be used to tie to otherbones or soft tissues. Likewise, if desired, supplemental sutures may beattached to one or both anchors and used to further reinforce the jointor adjacent joints and soft tissue, as shown in FIG. 22. As shown inFIG. 23, the exemplary reinforcement construct may also be used inconjunction with a bone plate 814.

Notably, while the syndesmosis reinforcement procedure 1100 is describedabove in relation to reinforcement of the interosseous ligament (IOL)114 (FIG. 3) between the tibia and fibula, the method could be used toform ligament reinforcement constructs that compress any two bonestogether to reduce the space between bones and/or to reinforce aligament across a bone joint to achieve optimal anatomic positioning inboth directional alignment and the reduction force applied by theconstruct.

Although the above embodiments have been described in language that isspecific to certain structures, elements, compositions, andmethodological steps, it is to be understood that the technology definedin the appended claims is not necessarily limited to the specificstructures, elements, compositions and/or steps described. Rather, thespecific aspects and steps are described as forms of implementing theclaimed technology. Since many embodiments of the technology can bepracticed without departing from the spirit and scope of the invention,the invention resides in the claims hereinafter appended.

What is claimed is:
 1. A clamp for compressing first and second boneportions together to reduce a space therebetween, comprising: a bodycomprising opposing first and second ends, the first and second endscomprising respective first and second jaws that define a longitudinalclamp axis, the first jaw engageable with the first bone portion and thesecond jaw engageable with the second bone portion to define adirectional force vector between the first and the second bone portionsthat is parallel with the longitudinal clamp axis; and an adjustmentmechanism coupled with the second jaw and configured to translate thesecond jaw distally toward the first jaw along the longitudinal axis tocompress the first and the second bone portions between the first andthe second jaws, the adjustment mechanism including a force gaugeconfigured to indicate a compression force placed upon the first and thesecond bone portions by the first and the second jaws along thedirectional force vector.
 2. The clamp of claim 1, wherein the clampfurther comprises a guide configured for insertion of a drill to formcoaxial bone tunnels, parallel with the longitudinal clamp axis, in thefirst and second bone portions.
 3. The clamp of claim 1, wherein theadjustment mechanism includes a gross adjustment control and a fineadjustment control.
 4. The clamp axis of claim 1, wherein the clampincludes finger grips and a thumb grip configured to enable one-handedoperation to apply compression force.
 5. The clamp of claim 1, whereinthe clamp includes a release trigger configured to release compressionforce.
 6. The clamp of claim 5, wherein the release trigger isconfigured to enable one-handed operation for both application ofcompression force and release of compression force.
 7. The clamp ofclaim 1, wherein the longitudinal clamp axis and the directional forcevector are parallel with a native ligament extending between the firstand the second bone portions.
 8. The clamp of claim 1, wherein: the bodyforms a bow-shaped angle gauge presenting a series of angle indicia; andwhen a reference line defined by a portion of a patient's anatomy alignswith a zero-degree marking on the angle indicia, the reference line isperpendicular to the longitudinal clamp axis and the directional forcevector.
 9. The clamp of claim 8, wherein the angle indicia on eitherside of the zero-degree marking indicate an amount of angular deviationbetween the reference line and the perpendicular.
 10. The clamp of claim1, wherein the first jaw comprises a v-notch configured to registerdirectly upon the first bone portion.
 11. The clamp of claim 1, whereinthe first jaw comprises a spherical end configured to register upon abone plate coupled with the first bone portion.
 12. The clamp axis ofclaim 11, wherein the clamp further comprises a guide configured forinsertion of a drill to form coaxial bone tunnels, parallel with thelongitudinal clamp axis, in the first and second bone portions, whereinthe coaxial bone tunnels are coaxial with a hole in the bone plate. 13.The clamp of claim 1, wherein the first end of the body comprises: aC-shaped arm that is coaxial with the longitudinal clamp axis; and asheath rotatively coupled about the C-shaped arm, the sheath forming aU-shaped groove that is coaxial with the longitudinal clamp axis,wherein: when the sheath is rotated into a closed configuration, a wallof the C-shaped arm aligns with the U-shaped groove such that theU-shaped groove is configured to receive and retain a longitudinalguide; and when the sheath is rotated into an open configuration, anopening of the C-shaped arm aligns with the U-shaped groove such thatthe clamp is transversely removable from the first and the second boneportions and the longitudinal guide.
 14. The clamp of claim 13, whereinthe longitudinal guide comprises a pin, a drill, or a length of k-wire.15. A tension instrument for tensioning and knotlessly locking aflexible strand having first and second opposing flexible strand ends,the first flexible strand end fixed adjacent to a first member and thesecond flexible strand end free proximal to the first member andadjacent to a second member, the tension instrument comprising: a memberengagement feature configured to engage with the second member throughwhich the second flexible strand end passes; and an adjustment mechanismoperably coupled to a proximal end of the member engagement feature, theadjustment mechanism including: a selectively adjustable flexible strandclamp configured to capture the second flexible strand end and translatethe second flexible strand end proximally relative to the memberengagement feature to place a tensile force on the flexible strandbetween the first and the second members; a force gauge operably coupledwith the selectively adjustable flexible strand clamp, the force gaugeincluding force indicia to provide an indication of the tensile forceplaced on the flexible strand; and a pathway extending through theadjustment mechanism from a proximal end to a distal end adjacent themember engagement feature to provide clearance for fixation hardwarethat knotlessly locks the second flexible strand end relative to thesecond member to maintain the tensile force between the first and thesecond flexible strand ends.
 16. The tension instrument of claim 15,wherein the adjustment mechanism includes a gross adjustment control anda fine adjustment control.
 17. The tension instrument of claim 15,wherein the clamp includes finger grips and a thumb grip configured toenable one-handed operation to apply compression force.
 18. The tensioninstrument of claim 15, wherein the clamp includes a release triggerconfigured to release compression force.
 19. The tension instrument ofclaim 18, wherein the release trigger is configured to enable one-handedoperation for both application of compression force and release ofcompression force.
 20. The tension instrument of claim 15, wherein atleast one of the first and the second members comprises a bone portion.21. The tension instrument of claim 15, wherein at least one of thefirst and the second members comprises a flexible strand fixationanchor.
 22. The tension instrument of claim 21, wherein the memberengagement feature comprises a fastener engagement feature configured toengage with the flexible strand fixation anchor.
 23. The tensioninstrument of claim 21, wherein the fastener engagement featurecomprises a pair of counter-torque prongs.
 24. The tension instrument ofclaim 15, wherein the pathway extending through the adjustment mechanismis a cannula.
 25. The tension instrument of claim 15, wherein thetensile force between the first and the second flexible strand ends isplaced only upon the flexible strand.
 26. The tension instrument ofclaim 15, wherein the adjustment mechanism further comprises: a handledisposed about the force gauge, the handle having a proximal end and adistal end; an outer shaft extending proximally to distally between theforce gauge and the member engagement feature; an inner shaft disposedwithin the outer shaft, the inner shaft extending proximally to distallybetween the proximal end of the handle and the member engagementfeature; a force spring disposed about the inner shaft in a spacebetween the inner shaft and the force gauge, the force spring extendingproximally to distally between the proximal end of the handle and theouter shaft, wherein an amount of force required to compress the forcespring is proportional to a distance the force spring is compressed; areceiver mounted upon the selectively adjustable flexible strand clamp,the receiver slidably coupled with the inner shaft, wherein: when themember engagement feature is engaged with the second member and thesecond flexible strand end is secured within the selectively adjustableflexible strand clamp, translating the receiver proximally relative tothe inner shaft forces the outer shaft and the force gauge distallyrelative to the inner shaft, thereby causing the handle to moveproximally over the force gauge against the force spring and compressingthe force spring such that the distal end of the handle aligns with oneof the force indicia indicating the tensile force placed on the flexiblestrand.
 27. A method of reinforcing a syndesmosis joint of a patientusing: a clamp having first and second opposing jaws that define alongitudinal clamp axis, and an adjustment mechanism configured to applya measurable compression force along a directional force vector betweenthe first and the second clamp jaws that is parallel with thelongitudinal clamp axis; and a tension instrument having an anchorengagement feature coupled with an adjustment mechanism configured placea measurable tensile force on a flexible strand extending between afirst anchor in a first bone portion and a second anchor in a secondbone portion, the method comprising: actuating the adjustment mechanismof the clamp to translate the second jaw of the clamp distally toachieve a desired compression force between the first and the secondbone portions along the directional force vector; noting the desiredcompression force reflected upon a force gauge of the adjustmentmechanism of the clamp; inserting a guide along the longitudinal clampaxis through the first jaw and into the first and the second boneportions to form a bone tunnel extending between the first and thesecond bone portions; and removing the clamp, leaving the guide inposition.
 28. The method of claim 27, wherein an angle gauge isconfigured to set an angle of the longitudinal clamp axis relative to areference line of a patient's anatomy, and further comprising using theangle gauge, positioning the clamp such that the first jaw is engagedwith the first bone portion and the second jaw is engaged with thesecond bone portion at a desired angle of the directional force vectorrelative to the reference line of the patient's anatomy.
 29. The methodof claim 27, further comprising: affixing a first end of a flexiblestrand to a first fixation anchor; using the guide, pulling a second endof the flexible strand through the bone tunnel to insert the firstfixation anchor into the bone tunnel at the second bone portion;threading the second end of the flexible strand through a secondfixation anchor; and inserting the second fixation anchor into the bonetunnel at the first bone portion.
 30. The method of claim 27, furthercomprising: engaging the anchor engagement feature of the tensioninstrument with the second fixation anchor; using the adjustmentmechanism of the tension instrument, pulling the second end of theflexible strand until a desired tensile force is placed on the flexiblestrand between the first and the second bone portions, as reflected upona force gauge of the adjustment mechanism of the tension instrument,wherein the desired tensile force equals the desired compression forceapplied through the clamp; and knotlessly locking the second end of theflexible strand in relation to the second fixation anchor.
 31. Themethod of claim 27, further comprising: accessing the second fixationanchor through a pathway through the tension instrument.
 32. The methodof claim 30, wherein the directional force vector parallels direction ofa native ligament extending between the first and the second boneportions.
 33. The method of claim 30, wherein the knotlessly locking thesecond end of the flexible strand comprises rotationally inserting a setscrew into a proximal portion of the second fixation anchor to create aninterference between the set screw, the flexible strand, and thefixation anchor.
 34. The method of claim 27, wherein the guide comprisesa drill, a pin, or a length of k-wire.